Handheld steering devices for intra vascular devices and associated systems and methods

ABSTRACT

Handheld steering devices for use with intravascular devices and associated systems and methods are disclosed. In some instances, the handheld steering device includes a housing sized and shaped for grasping by a hand of a user, the housing including a proximal portion and a distal portion, wherein the distal portion includes an opening sized and shaped to receive an intravascular device; an adaptor positioned within the opening of the housing, the adaptor including a bore sized and shaped to allow a proximal end of the intravascular device to pass therethrough; a steering controller coupled to the housing; and an actuator positioned within the housing and in communication with the steering controller, the actuator interfacing with the proximal end of the intravascular device based on inputs to the steering controller to steer a distal end of the intravascular device. Associated systems and methods are also disclosed.

PRIORITY CLAIM

This application is a continuation of U.S. patent application Ser. No.15/765,615 filed on Apr. 3, 2018 (now U.S. Pat. No. 11,147,513 issuedOct. 19, 2021), which claims priority to International PatentApplication Serial No. PCT/I132016/055732 filed on Sep. 26, 2016, whichclaims priority to U.S. Provisional Application Ser. No. 62/239,650filed on Oct. 9, 2015. Each of these documents is incorporated herein byreference.

TECHNICAL FIELD

The present disclosure relates to handheld steering devices for use withintravascular devices used in the diagnosis and treatment of variousmaladies. In particular, some embodiments disclosed herein areparticularly suited for use in intravascular and intracardiac diagnosticprocedures and/or treatments.

BACKGROUND

Innovations in diagnosing and verifying the level of success oftreatment of disease have migrated from external imaging processes tointernal diagnostic processes. In particular, diagnostic equipment andprocesses have been developed for diagnosing vasculature blockages andother vasculature disease by means of ultra-miniature sensors placedupon the distal end of a flexible elongate member such as a catheter, ora guide wire used for catheterization procedures. For example, knownmedical sensing techniques include angiography, intracardiacechocardiography (ICE), intravascular ultrasound (IVUS), forward lookingIVUS (FL-IVUS), pressure sensing (including associated fractional flowreserve (FFR) and instant wave-free ration (iFR) calculations), flowsensing (velocity and/or volumetric measurements, including associatedcoronary flow reserve (CPR) calculations), optical coherence tomography(OCT), trans-esophageal echocardiography, and various image-guidedtherapies. Each of these techniques may be better suited for differentdiagnostic and/or therapeutic situations. To increase the chance ofsuccessful treatment, health care facilities may have a multitude ofimaging, treatment, diagnostic, and/or sensing modalities on hand in acatheter lab during a procedure. In order to properly use any of theimaging, treatment, diagnostic, and/or sensing modalities, theassociated device must be accurately guided to the region of interestwithin the patient in a controlled manner without causing damage to theanatomy of the patient.

Accordingly, there remains a need for improved intravascular devices,systems, and methods to facilitate the guidance of one or more imaging,treatment, diagnostic, and/or sensing components to a region of interestwithin a patient.

SUMMARY

Embodiments of the present disclosure are directed to handheld steeringdevices for use with intravascular devices, including associated systemsand methods.

An intravascular steering device is provided that includes a housingsized and shaped for grasping by a hand of a user, the housing includinga proximal portion and a distal portion, wherein the distal portionincludes an opening sized and shaped to receive an intravascular device;an adaptor positioned within the opening of the housing, the adaptorincluding a bore sized and shaped to allow a proximal end of theintravascular device to pass therethrough; a steering controller coupledto the housing; and an actuator positioned within the housing and incommunication with the steering controller, the actuator interfacingwith the proximal end of the intravascular device based on inputs to thesteering controller to steer a distal end of the intravascular device.

The steering controller can include a joystick. The actuator can includea first mechanism for controlling movement in a first dimension; and asecond mechanism for controlling movement in a second dimensionperpendicular to the first dimension. The first and second mechanismscan each include a motor, a pull-wire wheel, and a pull-wire. Theactuator can further include a third mechanism for controlling movementin a third dimension, the third dimension being perpendicular to thefirst and second dimensions. The actuator can further include amechanism for controlling rotation of the intravascular device about alongitudinal axis of the intravascular device. The intravascularsteering device can further include a microcontroller positioned withinthe housing and in communication with the steering controller and theactuator, wherein the microcontroller translates inputs from thesteering controller into actuation signals for the actuator. Theintravascular steering device can further include a haptic feedbackdevice positioned within the housing and configured to provide an alertto a user when a force on the intravascular device exceeds a threshold.The force on the intravascular device can be measured by at least one ofa sensor within the housing or a sensor within the intravascular device.The intravascular steering device can further include a rechargeablepower supply positioned within the housing; and a wireless transceiverpositioned within the housing.

An intravascular steering system is also provided that includes anintravascular device having a proximal section and a distal section,wherein at least one sensing component is coupled to the distal section;and an intravascular steering device having: a housing sized and shapedfor grasping by a hand of a user, the housing including a proximalportion and a distal portion, wherein the distal portion includes anopening sized and shaped to receive the proximal section of theintravascular device; an adaptor positioned within the opening of thehousing, the adaptor including a bore sized and shaped to allow theproximal section of the intravascular device to pass therethrough; asteering controller coupled to the housing; and an actuator positionedwithin the housing and in communication with the steering controller,the actuator interfacing with the proximal section of the intravasculardevice based on inputs to the steering controller to steer the distalsection of the intravascular device.

A method of steering an intravascular device is also provided thatincludes providing an intravascular steering device having: a housingsized and shaped for grasping by a hand of a user, the housing includinga proximal portion and a distal portion, wherein the distal portionincludes an opening sized and shaped to receive a proximal section of anintravascular device; an adaptor positioned within the opening of thehousing, the adaptor including a bore sized and shaped to allow theproximal section of the intravascular device to pass therethrough; asteering controller coupled to the housing; and an actuator positionedwithin the housing and in communication with the steering controller;coupling an intravascular device to the intravascular steering device byintroducing a proximal section of the intravascular device through theopening in the housing and through the bore in the adaptor; andutilizing the intravascular steering device to guide the intravasculardevice to a target location within a patient, wherein inputs to thesteering controller cause the actuator to interface with the proximalsection of the intravascular device to steer a distal section of theintravascular device.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure will be describedwith reference to the accompanying drawings, of which:

FIG. 1 is a perspective view of an intravascular system including ahandheld steering device and an intravascular device according to thepresent disclosure.

FIG. 2 is a side view of the intravascular system of FIG. 1 showingsteering of the intravascular device by the handheld steering device ina first dimension (e.g., up and down).

FIG. 3 is a top view of the intravascular system of FIGS. 1 and 2showing steering of the intravascular device by the handheld steeringdevice in a second dimension (e.g., left and right), the seconddimension being perpendicular to the first dimension shown in FIG. 2.

FIG. 4 is a top view of the intravascular system of FIGS. 1-3 showingtranslation of the intravascular device by the handheld steering devicein a third dimension (e.g., forward and backward), the third dimensionbeing perpendicular to the first and second dimensions shown in FIGS. 2and 3.

FIG. 5 is a top view of the intravascular system of FIGS. 1-4 showingrotation (e.g., clockwise and/or counter-clockwise) of the intravasculardevice by the handheld steering device.

FIG. 6A is a top view of the handheld steering device of FIGS. 1-5.

FIG. 6B is a top view of the handheld steering device similar to that ofFIG. 6A, but with a top portion of a housing of the handheld steeringdevice removed to reveal inner components of the handheld steeringdevice.

FIG. 6C is a top view of the handheld steering device similar to that ofFIG. 6B, but showing an intravascular device engaged with the handheldsteering device.

FIG. 7 is an exploded, perspective view of the handheld steering deviceof FIGS. 1-6C.

FIG. 8 is a bottom view of a top portion of a housing of the handheldsteering device.

FIG. 9 is a top view of a bottom portion of a housing of the handheldsteering device.

FIG. 10A is a front view of a shaft adapter of the handheld steeringdevice.

FIG. 10B is a side view of the shaft adapter of FIG. 10A.

FIG. 11A is a front view of a shaft adapter of the handheld steeringdevice.

FIG. 11B is a side view of the shaft adapter of FIG. 11A.

FIG. 12A is a front view of a pull-wire wheel of the handheld steeringdevice.

FIG. 12B is a back view of the pull-wire wheel of FIG. 12A.

FIG. 12C is a perspective view of the pull-wire wheel of FIGS. 12A and12B.

FIG. 13A is a side view of the handheld steering device of FIGS. 1-7.

FIG. 13B is a side view of the handheld steering device similar to thatof FIG. 13A, but with a top portion of a housing of the handheldsteering device removed to reveal inner components of the handheldsteering device.

FIG. 14A is a side view of the handheld steering device similar to thatof FIG. 13A, but from the opposing side.

FIG. 14B is a side view of the handheld steering device similar to thatof FIG. 14A, but with a top portion of a housing of the handheldsteering device removed to reveal inner components of the handheldsteering device.

FIG. 15A is a top view of a handheld steering device having a scrollwheel for controlling translation of an intravascular device.

FIG. 15B is a top view of a handheld steering device having a scrollwheel for controlling rotation of an intravascular device.

FIG. 15C is a top view of a handheld steering device having a scrollwheels for controlling rotation and/or translation of an intravasculardevice.

For clarity of discussion, elements having the same designation in thedrawings may have the same or similar functions. The drawings may bebetter understood by referring to the following detailed description.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It is nevertheless understood that no limitation tothe scope of the disclosure is intended. Any alterations and furthermodifications to the described devices, systems, and methods, and anyfurther application of the principles of the present disclosure arefully contemplated and included within the present disclosure as wouldnormally occur to one skilled in the art to which the disclosurerelates. In particular, it is fully contemplated that the features,components, and/or steps described with respect to one embodiment may becombined with the features, components, and/or steps described withrespect to other embodiments of the present disclosure. For the sake ofbrevity, however, the numerous iterations of these combinations will notbe described separately.

As used herein, “flexible elongate member” or “elongate flexible member”includes at least any thin, long, flexible structure that can beinserted into the vasculature of a patient.

While the illustrated embodiments of the “flexible elongate members” ofthe present disclosure have a cylindrical profile with a circularcross-sectional profile that defines an outer diameter of the flexibleelongate member, in other instances all or a portion of the flexibleelongate members may have other geometric cross-sectional profiles(e.g., oval, rectangular, square, elliptical, etc.) or non-geometriccross-sectional profiles. Flexible elongate members include, forexample, guide wires and catheters. In that regard, catheters may or maynot include a lumen extending along its length for receiving and/orguiding other instruments. If the catheter includes a lumen, the lumenmay be centered or offset with respect to the cross-sectional profile ofthe device.

In most embodiments, the flexible elongate members of the presentdisclosure include one or more electronic, optical, or electro-opticalcomponents. For example, without limitation, a flexible elongate membermay include one or more of the following types of components: a pressuresensor, a flow sensor, a temperature sensor, an imaging element, anoptical fiber, an ultrasound transducer, a reflector, a mirror, a prism,an ablation element, an RF electrode, a conductor, and/or combinationsthereof. Generally, these components are configured to obtain datarelated to a vessel or other portion of the anatomy in which theflexible elongate member is disposed. Often the components are alsoconfigured to communicate the data to an external device for processingand/or display. In some aspects, embodiments of the present disclosureinclude imaging devices for imaging within the lumen of a vessel,including both medical and non-medical applications. However, someembodiments of the present disclosure are particularly suited for use inthe context of human vasculature. Imaging of the intravascular space,particularly the interior walls of human vasculature can be accomplishedby a number of different techniques, including ultrasound (oftenreferred to as intravascular ultrasound (“IVUS”) and intracardiacechocardiography (“ICE”)) and optical coherence tomography (“OCT”). Inother instances, infrared, thermal, or other imaging modalities areutilized.

The electronic, optical, and/or electro-optical components of thepresent disclosure are often disposed within a distal portion of theflexible elongate member. As used herein, “distal portion” of theflexible elongate member includes any portion of the flexible elongatemember from the mid-point to the distal tip. As flexible elongatemembers can be solid, some embodiments of the present disclosure willinclude a housing portion at the distal portion for receiving theelectronic components. Such housing portions can be tubular structuresattached to the distal portion of the elongate member. Some flexibleelongate members are tubular and have one or more lumens in which theelectronic components can be positioned within the distal portion.

The electronic, optical, and/or electro-optical components and theassociated communication lines are sized and shaped to allow for thediameter of the flexible elongate member to be very small. For example,the outside diameter of the elongate member, such as a guide wire orcatheter, containing one or more electronic, optical, and/orelectro-optical components as described herein are between about 0.0007″(0.0178 mm) and about 0.118″ (3.0 mm), with some particular embodimentshaving outer diameters of approximately 0.014″ (0.3556 mm),approximately 0.018″ (0.4572 mm), and approximately 0.035″ (0.889 mm).As such, the flexible elongate members incorporating the electronic,optical, and/or electro-optical component(s) of the present applicationare suitable for use in a wide variety of lumens within a human patientbesides those that are part or immediately surround the heart, includingveins and arteries of the extremities, renal arteries, blood vessels inand around the brain, and other lumens.

“Connected” and variations thereof as used herein includes directconnections, such as being glued or otherwise fastened directly to, on,within, etc. another element, as well as indirect connections where oneor more elements are disposed between the connected elements. “Secured”and variations thereof as used herein includes methods by which anelement is directly secured to another element, such as being glued orotherwise fastened directly to, on, within, etc. another element, aswell as indirect techniques of securing two elements together where oneor more elements are disposed between the secured elements.

Referring now to FIG. 1, shown therein is a system 100 that includes anintravascular device 102 and a steering device 110. As discussed ingreater detail below, a proximal portion of the intravascular device 102is engaged with the steering device 110 such that the steering device110 can be utilized to steer a distal portion of the intravasculardevice 102. In this regard, the steering device 110 provides a user withan ergonomic and intuitive controller for accurately and preciselycontrolling the movement of a disposable intravascular device (e.g.,multi-planar steering, withdrawal, advancement, rotational, and/orcombinations thereof) within a patient. As a result, the steering device110 provides many advantages and improvements over existing approaches,including without limitation: single hand operation/control in allactuation directions, simple and intuitive functional interface,improved actuation precision including speed and angle differentiation,fast yet controlled actuation response, minimum user force inputrequired for actuation (actuation strength limited by motorspecifications instead of user comfort), ability to use with manydifferent types of intravascular devices with varyingprofiles/characteristics, safety lock and return to neutral positionfunctionalities, minimum bend radius, reduced body sway when actuatingthe distal tip, better torque response, disposable, lower cost, easiermanufacturability and assembly, modular componentry to facilitate simplemanufacture and/or assembly of numerous specialized devices.

The steering device 110 can also be implemented with various advancedcontrol features to further improve the functionality of the device andassociated user experience. For example, the steering device 110 mayinclude one or more of the following features: memory for storing andrecalling position(s) and/or actuation angle(s) in a controlled manner,including allowing the setting of different positions as the neutralintravascular device position, providing the user accurate feedback onthe intravascular device's position/actuation angle relative to home(neutral) position, allowing control of the steering device by a remoteuser (e.g., at the system console, in a separate room, and/or across theworld), multi-level actuation controls (e.g., coarse, fine, etc.),logging actuation usage for complaint handling and/or casedocumentation, providing automated 3D anatomical mapping of the vessels,heart, or other structures when used in conjunction with intravasculardevices having imaging elements, and producing more consistent devicecontrol through in line calibrations for both first time device use andrepeated uses after reprocessing, which can reduce unit to unitvariation and compensate for the effects of wear and tear on thesteering device and/or intravascular device.

The intravascular device 102 includes a flexible elongate member havinga distal portion 104 adjacent a distal end and a proximal portion 106adjacent a proximal end. A component 108 is positioned within the distalportion 104 of the flexible elongate member proximal of the distal end.Generally, the component 108 is representative of one or moreelectronic, optical, or electro-optical components. In that regard, thecomponent 108 can include an imaging element, an optical fiber, anultrasound transducer, a reflector, a mirror, a prism, an ablationelement, an RF electrode, a pressure sensor, a flow sensor, atemperature sensor, a conductor, and/or combinations thereof Thespecific type of component or combination of components can be selectedbased on an intended use of the intravascular device. In some instances,the component 108 is positioned less than 10 cm, less than 5, or lessthan 3 cm from the distal tip 105. In some instances, the component 108is positioned within a housing of the intravascular device 102. In thatregard, the housing is a separate component secured to the flexibleelongate member in some instances. In other instances, the housing isintegrally formed as a part of the flexible elongate member.

In some instances, the intravascular device 102 also includes aconnector adjacent the proximal portion 106 of the device. In thatregard, the connector can be at the proximal end of the flexibleelongate member or spaced from the proximal end of the flexible elongatemember. Generally, the spacing from the proximal end can be between 0%and 50% of the total length of the flexible elongate member. While thetotal length of the flexible elongate member can be any length, in someembodiments the total length is between about 1300 mm and about 4000 mm,with some specific embodiments having a length of 1400 mm, 1900 mm, and3000 mm. Accordingly, in some instances the connector is positioned atthe proximal end. In other instances, the connector is spaced from theproximal end. For example, in some instances the connector is spacedfrom the proximal end between about 0 mm and about 1400 mm. In somespecific embodiments, the connector is spaced from the proximal end by adistance of 0 mm, 300 mm, and 1400 mm. In some implementations, theconnector is positioned at or adjacent to the proximal end of theintravascular device 102 such that the connector engages a matingconnector within the steering device 110 when the intravascular device102 is coupled with the steering device 110. In other implementations,the connector is spaced from the proximal end of the intravasculardevice 102 such that the connector is positioned outside of the steeringdevice 110 when the intravascular device 102 is coupled with thesteering device 110, which can allow selective coupling of the connectorto a mating connector separate from the steering device 110.

The connector is configured to facilitate communication between theintravascular device 102 and another device. More specifically, in someembodiments the connector is configured to facilitate communication ofdata obtained by the component 108 to another device, such as acomputing device or processor. Accordingly, in some embodiments theconnector is an electrical connector. In such instances, the connectorprovides an electrical connection to one or more electrical conductorsthat extend along the length of the intravascular device 102 and areelectrically coupled to the component 108. In some embodiments theelectrical conductors are embedded within a core of the flexibleelongate member. In other embodiments, the connector is an opticalconnector. In such instances, the connector provides an opticalconnection to one or more optical communication pathways (e.g., fiberoptic cable) that extend along the length of the intravascular device102 and are optically coupled to the component 108. Similarly, in someembodiments the optical fibers are embedded within a core of theflexible elongate member. Further, in some embodiments the connectorprovides both electrical and optical connections to both electricalconductor(s) and optical communication pathway(s) coupled to thecomponent 108. In that regard, it should be noted that component 108 canbe comprised of a plurality of elements. The connector can be configuredto provide a physical connection to another device, either directly orindirectly. The connector can also be configured to facilitate wirelesscommunication between the intravascular device 102 and another device.Generally, any current or future developed wireless protocol(s) may beutilized. In yet other instances, the connector facilitates bothphysical and wireless connection to another device.

As noted above, in some instances the connector provides a connectionbetween the component 108 of the intravascular device 102 and anexternal device. Accordingly, in some embodiments one or more electricalconductors, one or more optical pathways, and/or combinations thereofextend along the length of the intravascular device 102 between theconnector and the component 108 to facilitate communication between theconnector and the component 108. Generally, any number of electricalconductors, optical pathways, and/or combinations thereof can extendalong the length of the intravascular device 102 between the connectorand the component 108, embedded in the core or not. In some instances,between one and ten electrical conductors and/or optical pathways extendalong the length of the intravascular device 102 between the connectorat the proximal portion 106 and the component 108 at the distal portion104. The number of communication pathways and the number of electricalconductors and optical pathways extending along the length of theintravascular device 102 is determined by the desired functionality ofthe component 108 and the corresponding elements that define component108 to provide such functionality.

As noted above, the steering device 110 is configured to controlmovement of the distal portion 104 of the intravascular device 102 byinterfacing with the proximal portion 106 of the intravascular device102. In this regard, the steering device 110 can be configured tocontrol movement of the distal portion 104 of the intravascular device102 in one or more dimensions. For example, FIGS. 2-5 show various typesof movements that can be controlled by the steering device 110.Referring to FIG. 2, the steering device 110 is shown controllingmovement of the distal portion 104 of the intravascular device 102 in afirst dimension (e.g., up and down relative to the steering device 110).Referring to FIG. 3, the steering device 110 is shown controllingmovement of the distal portion 104 of the intravascular device 102 in asecond dimension (e.g., left and right relative to the steering device110) that is perpendicular to the dimension shown in FIG. 2. While FIGS.2 and 3 show particular, exemplary deviations of the distal portion 104of the intravascular device 102 in the noted dimensions, it isunderstood that actuation of the steering device 110 in a particulardirection can cause the distal tip of the intravascular device 102 tomove between 0 degrees and 180 degrees (or more) in that directiondepending on the amount of actuation imparted by the user. Accordingly,in some implementations continued actuation of

the steering device 110 in a particular direction can cause the distalportion 104 of the intravascular device 102 to contact and/or loop nextto a more proximal portion of the intravascular device 102.

Referring to FIG. 4, the steering device 110 is shown controllingmovement of the distal portion 104 of the intravascular device 102 in athird dimension (e.g., forward and backward relative to the steeringdevice 110) that is perpendicular to the dimensions shown in FIGS. 2 and3. In particular, FIG. 4 shows the steering device 110 controllingtranslation of the intravascular device 102 along a longitudinal axis ofthe intravascular device. In some implementations, the steering device110 can be utilized to precisely control the advancement or retractionof the intravascular device 102 through a patient, including thedistance, speed, and/or combination thereof. In this regard, thesteering device 110 can be utilized to perform pullback procedures toobtain data over a length of a region of interest within the patient.

Referring to FIG. 5, the steering device 110 is shown controllingrotation of the distal portion 104 of the intravascular device 102 abouta longitudinal axis of the intravascular device. In someimplementations, the steering device 110 can be utilized to preciselycontrol the rotational position of the distal portion 104 of theintravascular device 102 to facilitate aiming or positioning of thedistal portion 104 of the intravascular device in a desired manner. Forexample, this can be useful for ablation procedures, repositioning asensing element (e.g., when an ambient opening for a pressure sensor ispositioned against a vessel wall, rotation of the distal portion of theintravascular device can move the opening towards the center of thevessel to improve the accuracy of pressure measurements), and/or otherinstances where a rotational orientation of the intravascular device 102can affect the diagnosis and/or treatment.

The steering device 110 can be configured to control movement of thedistal portion 104 of the intravascular device 102 in one or more of themanners shown in FIGS. 2-5, including all of them in someimplementations. The particular movement(s) that the steering device 110is configured to control may be selected based on the type(s) ofintravascular devices the steering device is to be used with, userpreference, and/or other factors. Further, it is understood that varioustypes of electro-mechanical, mechanical, pneumatic, optical-mechanicalcomponents, and/or combinations thereof can be utilized within thesteering device 110 to impart forces on the proximal portion 106 of theintravascular device 102 to control the movement of the distal portion104 of the intravascular device 102 in the desired direction(s). Someexemplary approaches and components are described below, but this doesnot limit the types of approaches or components that can be utilizedwithin the steering device 110 to impart such movements.

Referring now to FIGS. 6A-14B, additional details of the steering device110 will be described. Referring initially to FIG. 6A, the steeringdevice 110 includes a housing 112 having a proximal portion 114 and adistal portion 116. The housing 112 is sized and shaped for grasping bya single hand of a user. It is understood that the housing 112 may havemany different geometries suitable for handheld use other than thoseshown in the present disclosure. The steering device 110 also includes asteering controller 118 coupled to the housing 112. The steeringcontroller 118 can be any suitable type of controller including withoutlimitation a joystick (as shown), dial, track pad, scroll wheel,touchscreen, and/or combinations thereof. In short, the steeringcontroller 118 should be able to receive user inputs indicative of adesired movement of the distal portion 104 of the intravascular device102. The steering controller 118 may include multiple controls in someinstances. For example, the steering controller 118 may include separatecontrol for each dimension or a separate control for a combination ofdimensions (e.g., a control for x-y movements).

A single thumb joystick can be particular suitable for controllingsteering of the distal portion of the intravascular device 102 in alldirections. In this regard, the joystick circuit can include a biaxialpotentiometer design with a digital button pin press function. Thejoystick circuit can be connected to a microcontroller. Through softwareand/or firmware coding, a variety of functions can be controlled througha single joystick. For example, the use of a single click, doubleclicks, press for duration, etc. can be utilized to toggle the joystickbetween different functions/controls. However, additional buttonscontrolling specific handle functionalities (e.g. on/off switch, lockbutton, etc.) can be included in addition to the joystick for userconvenience and ease of use.

As shown in FIGS. 6B, 6C, 13B, and 14B, the steering controller 118 iscoupled to a mount 120. The mount 120 is coupled to the housing 112. Themount 120 is sized and shaped such that when the steering controller 118is positioned on the mount 120, the steering controller 118 ispositioned at a desired orientation with respect to the housing 112. Inthis regard, the structure of the mount 120 can be selected based onstructural aspects of the steering controller 118 and/or the housing tofacilitate the desired alignment of the steering controller 118 withrespect to the housing 112. In the illustrated embodiment, the mount 120is coupled to the housing 112. In particular, the mount 120 is coupledto a lower housing portion 112 b with the help of keyed interfaces(circular keyed interface below the mount 120 for centering, andhorizontal keyed interfaces with the side walls for vertical alignmentand to prevent rotation.

As shown in FIGS. 6B, 6C, 7, 13B, and 14B, the steering device 110includes pull-wire wheels 122 and 124, pull-wires 123 and 125 (FIG. 6C),motors 126 and 128, mounting structures 130 and 132, and guide pins 134and 136. In this regard, motor 126 is coupled to pull-wire wheel 122 tocontrol movement of the intravascular device 102 in a first dimension(e.g., up and down), while motor 128 is coupled to pull-wire wheel 124to control movement of the intravascular device 102 in a seconddimension (e.g., left and right). The motors 126 and 128 are mountedonto the mounting structures 130 and 132, which are coupled to thehousing 112. The mount structures 130 and 132 are sized and shaped suchthat when the motors 126 and 128 are positioned on the mountingstructures 130 and 132, the pull-wire wheels 122 and 124 mounted to themotors 126 and 128, respectively, will be positioned at a desiredlocation with respect to the guide pins 134 and 136. In this regard, theguide pins 134 and 136 can be utilized to tension the pull-wires 123 and125 that interface with the proximal portion 106 of the intravasculardevice 102.

More specifically, the pull-wires 123 and 125 exit the pull-wire wheels122 and 124 and are routed around the guide pins 134 and 136 such thatwhen the intravascular device 102 is received within the steering device110 the pull-wires 123 and 125 will interface with the proximal portionof the intravascular device 102. The guide pins 134 and 136 can beslotted into the housing 112 to provide a safe and controlled pathwayfor the pull-wires 123 and 125 to navigate to the pull-wire wheels 122and 124. The guide pins 134 and 136 can be of various geometries tocontrol the angle and pathway of the pull-wires 123 and 125. In additionto or as an alternative to the guide pins 134 and 136, the steeringdevice 110 can include grooves, slots, projections, tapers, and/or otherstructures integrally formed as part of the housing 112 to safely guidethe pull-wires 123 and 125.

Selective actuation of the motors 126 and 128 in response to user inputsto the steering controller 118 imparts tension on the pull-wires 123 and125 in a particular direction (based on the direction of rotation of themotor and associated pull-wire wheel corresponding to the user inputs),causing the proximal portion 106 of the intravascular device 102 to bemoved in a corresponding manner and imparting movement to the distalportion 104 of the intravascular device 102. In the illustratedembodiment, two pull-wire wheels 122 and 124 attached to two differentmotors 126 and 128 are controlled by a single steering controller 118 (ajoystick with biaxial potentiometer in the illustrated embodiment) tofacilitate steering of the intravascular device in all directions in aplane extending perpendicular to a longitudinal axis of theintravascular device.

FIGS. 12A-12C illustrate additional aspects of the pull-wire wheels 122and 124. The pull-wire wheels 122 and 124 are sized and shaped tofacilitate steering precision in a repeatable manner. All surfacescontacting the pull-wires 123 and 125 are radiused or curved to preventsharp edges from biting into the pull-wire material. The pull-wirewheels 122 and 124 are configured to interface with the motors 126 and128. In this regard, the pull-wire wheels 122 and 124 include a notchedor keyed opening 200 to engage with a corresponding notched or keyedwheel of the motors 126 and 128.

The pull-wire wheels 122 and 124 also include anchor structures 202 and204 that are in communication with a partially enclosed pull-wire track206. In this regard, the internal pull-wire track 206 prevents thepull-wires 123 and 125 from misaligning as pull-wires cycle throughperiods of relaxation and high tension as the intravascular device 102is steered in various directions. The internal pull-wire track 206 alsohelps ensure that the pull-wire location at high tension relative to thewheel itself is more consistent through several actuations, allowing formore flexible placement of the wheels relative to the proximal end ofthe intravascular device 102. The pull-wires 123 and 125 are threadthrough the internal pull-wire tracks of the pull-wire wheels 122 and124, secured around the anchor structures 202 and 204, and terminated.

The pull-wire wheels 122 and 124 include openings 208 through which thepull-wires 123 and 125 extend to the guide pins 134 and 136 forinterfacing with the proximal end of the intravascular device 102. Inthis regard, the angle of the openings 208 can be optimized to maximizethe actuation of the steering device 110 (e.g., to achieve greatest netforce created when steering in a particular direction). The optimalangle will be dependent on such factors as the pathway of the pull-wires123 and 125 to the pull-wire wheels 122 and 124, the relative locationof the pull-wire wheels 122 and 124 to the proximal end of theintravascular device 102, and the range of the motors being used, etc.

The motors 126 and 128 can include stepper motors, servo motors, and/orother suitable motor. The motors can be mounted either on fixed bracketsattached to or integrally formed with the housing or onto removablebrackets, such as the mounting structures 130 and 132, that areremovably coupled to the housing 112 (e.g., through a keyed orinterlocking interface). The use of removable brackets can allow formore flexibility in motor selection and actuation design for thesteering device 110. For example, several different mounting structurescan be provided for used with a variety of different motors and/or otheractuating mechanism for use within the same housing 112.

Further, in some instances some or all components of the actuator system(e.g., motors 126 and 128, the mounting structures 130 and 132, and/orthe guide pins 134 and 136) can be attached to a rail or track extendingalong a length of the housing 112. In this regard, the actuator systemcan be moved along the length of the housing 112 to facilitatetranslational movement of the intravascular device, alone or incombination with other directional movements. Movement of the actuatorsystem can be accomplished using a gear and chain mechanism coupled to amotor or other suitable translation mechanism. If translationalactuation is provided by the steering device 110, then the steeringdevice 110 may receive inputs regarding the desired translation from thesteering controller 118. In some instances, a mode of operation of thesteering controller 118 is selected/changed to distinguish betweenz-dimension steering inputs (i.e., forward and backward) and x-ysteering inputs (i.e., up, down, left, and right). Alternatively, thesteering device may include a separate controller to receive inputs withrespect to the desired translation actuation. For example, FIG. 15Aillustrates a steering device 110 with a separate controller 210 forcontrolling translational movement of the intravascular device 102. Inthe illustrated embodiment, the controller 210 is a scroll wheel, butother controller such as a joystick, dial, track pad, touchscreen, etc.may be utilized.

If rotational actuation is provided by the steering device 110, then thesteering device 110 may receive inputs regarding the desired rotationfrom the steering controller 118. In some instances, a mode of operationof the steering controller 118 is selected/changed to distinguishbetween rotational steering inputs (i.e., clockwise and/orcounter-clockwise about the longitudinal axis of the intravasculardevice) and x-y-z dimension steering inputs (i.e., forward, backward,up, down, left, and/or right). Alternatively, the steering device mayinclude a separate controller to receive inputs with respect to thedesired rotational actuation. For example, FIG. 15B illustrates asteering device 110 with a separate controller 212 for controllingrotational movement of the intravascular device 102. In the illustratedembodiment, the controller 212 is a scroll wheel, but other controllersuch as a joystick, dial, track pad, touchscreen, etc. may be utilized.Further, FIG. 15C illustrates a steering device 110 with separatecontrollers 210 and 212 for controlling translation and rotationalmovement of the intravascular device 102, respectively.

The range of rotation imparted by the scroll wheel can restricted toprevent over torquing the intravascular device. In this regard, therange of rotation can be restricted mechanically and/or electronically.For example, the scroll wheel may provide a mechanical interface to theintravascular device such that rotation of intravascular device isdirectly proportional to the range of motion of the scroll wheel. Insuch instances, the scroll wheel may include stops that limit a range ofmotion of the scroll wheel to a desired range (e.g., 90 degrees, 180degrees, 270 degrees, 360 degrees, 450 degrees, 540 degrees, or othersuitable range) and, thereby, limit the range of rotation of theintravascular device.

Similarly, the range of rotation can be electronically controlled wherean electro-mechanical interface is utilized to control rotation. Forexample, where inputs to the scroll wheel are converted intocorresponding actuation of a motor and keyed/geared interface to causerotation of the intravascular device, the range of the motor can beelectronically limited to stay within the desired range of rotation. Insome instances, there is no limitation to the range of rotation. Forexample, in some implementations it may be desirable to repeatedlyrotate the intravascular device or a portion thereof (such as aninternal drive shaft). In such instances, DC motors can be used whererapid rotational actuation is desired (e.g., rotating a drive shaftcoupled to an imaging element, such as an IVUS transducer or OCTelement, at the distal portion of the intravascular device).

As shown in FIGS. 6B, 6C, 7, 10A, 10B, 11A, 11B, 13B, and 14B, tofacilitate secure, but removable engagement of the proximal portion 106of the intravascular device 102 with the steering device 110, thesteering device 110 includes an adaptor 138. The adaptor is positionedwithin an opening in the distal portion of the housing 112 that is sizedand shaped to receive an intravascular device. However, the opening inthe housing 112 may be large enough to receive intravascular devices ofvarious sizes such that the steering device 110 is suitable for use witha variety of different intravascular devices. Accordingly, the size ofthe adaptor 138 can be selected based on the particular intravasculardevice(s) that the steering device 110 will be used with. In thisregard, in some instances the steering device 110 is provided with aplurality of adaptors 138 of varying sizes to allow the user to selectand install the appropriate adaptor 138 within the steering device.

FIGS. 10A and 10B illustrate an embodiment of the adaptor 138 having abore 190 extending therethrough. The bore 190 is sized and shaped toallow the proximal end of an intravascular device to pass therethroughto interface with the steering actuators of the steering device 110 (asshown in FIG. 6C, for example). However, the bore 190 is also sized andshaped to provide an interference fit with the proximal portion of theintravascular device 102 such that the intravascular device 102 remainsengaged with the steering device 110. Accordingly, in someimplementations the bore 190 is sized to be equal to or smaller than theouter diameter of the proximal portion 106 of the intravascular device102. In this regard, the adaptor 138 can be formed of a material withsufficient flexibility to allow slight deformation of the adaptor 138(e.g., expansion of the bore 190) such that the intravascular device 102can be selectively inserted and removed from the adaptor 138.

FIGS. 11A and 11B illustrate an embodiment of the adaptor 138 having avariable bore 192 extending therethrough. In particular, the bore 192includes a section 194 and a section 196. The section 194 has a largerdiameter than the section 196, as shown. In some implementations, thesections 194 and 196 are configured to receive and/or engage differentportions of an intravascular device. For example, the section 194 can besized and shaped to receive an outer sleeve or jacket of anintravascular device, while the section 196 is sized and shaped to allowan inner shaft of the intravascular device to pass therethrough tointerface with the steering actuators of the steering device 110. Insome specific implementations, the section 194 loosely engages the outersleeve or jacket such that the outer sleeve or jacket is rotatable withrespect to the adaptor 138, while the section 196 has an interferencefit with the inner shaft of the intravascular device. Using such aninterface, the outer sleeve or jacket of the intravascular device can beheld in place with respect to the steering device 110 via a keyedinterface that prevents separation, but still allows for rotationalactuation of the outer sleeve or jacket.

In the illustrated embodiment, the adaptor 138 is positioned within thehousing 112. However, in some embodiments, the adaptor 138 is part of aseparate component attachable to the distal end of the external handlehousing. In this situation, the pull-wires 123 and 125 associated withthe pull-wire wheels 122 and 124 can include mating mechanisms tointerface with corresponding pull-wires of the separate componentcontaining the adaptor 138. In this manner, a universal handle withsteering wires can be provided and then separate add-on components withappropriately sized adaptors can be provided for different types andsizes of intravascular devices. The pull-wires and mating components canbe placed in alignment with one another along the surfaces of theattachable adapter and the distal surface of the housing for ease ofattachment (e.g., single click and rotation to mate all the pull-wirestogether and lock the adaptor securely in place with respect to thehousing 112). The attachable modular shaft adapter concept allows forquick replacement and immediate handle integration of a variety of shafttypes and devices during manufacturing, reprocessing, and/or during adiagnostic/treatment procedure.

As shown in FIGS. 6B, 6C, 7, 13B, and 14B, the steering device 110includes a microcontroller 140. The microcontroller 140 can be utilizedto control the logic and store the data and/or program code necessaryfor actuation and/or advanced features of the steering device 110. Inthis regard, it is understood that the microcontroller 140 can include aprocessor, which may be implemented using a general-purpose processor, adigital signal processor (DSP), an application specific integratedcircuit (ASIC), a field programmable gate array (FPGA) or otherprogrammable logic device, discrete gate or transistor logic, discretehardware components, or any combination thereof designed to perform thefunctions described herein. The processor may also be implemented as acombination of computing devices, e.g., a combination of a DSP and amicroprocessor, a plurality of microprocessors, one or moremicroprocessors in conjunction with a DSP core, or any other suchconfiguration.

It is also understood that the microcontroller 140 can include memory,which may include random access memory (RAM), read-only memory (ROM),flash memory devices in RAM, optical storage media, erasableprogrammable read-only memory (EPROM), registers, or combinationsthereof, including a non-transitory computer-readable medium.Instructions or code may be stored in the memory of the microcontroller140 that are executable by a processor of the microcontroller. The terms“instructions” and “code” should be interpreted broadly to include anytype of computer-readable statement(s). For example, the terms“instructions” and “code” may refer to one or more programs, routines,sub-routines, functions, procedures, etc. “Instructions” and “code” mayinclude a single computer-readable statement or many computer-readablestatements.

The microcontroller 140 can power the motors and/or other actuatorsneeded for the full range of steering actuations provided by thesteering device 110. The microcontroller 140 can be powered through awired interface with an external device (e.g., processing system,console, etc.) or via a rechargeable power supply (e.g., one or morebatteries, capacitors, etc.) within the housing 112. To this end, amounting structure 142 onto which the microcontroller 140 is mountedwithin the housing 112 can be and/or include one or more power supplies.Alternatively, the power supply can be positioned elsewhere within thehousing 112 and/or removably coupled to the housing 112.

As shown in FIG. 6A, the steering device 110 can include indicatorlights 144, 146, and 148. The indicator lights 144, 146, and 148 canprovide various indications to the user as to the state of the steeringdevice 110 and/or the intravascular device 102. The indicator lights144, 146, and 148 may be provided in addition to other notifications tothe user, for example via a graphical user interface of an associatedprocessing system. The indicator lights can provide a wide variety ofnotifications to the user, include without limitation: on/off, device atHOME position, device at STORED position, device moving to HOME, devicemoving to STORED position, device position locked, motor(s) at maxedposition in a particular direction, etc. In this regard, the indicatorlights 144, 146, and 148 can be part of or in communication with themicrocontroller 140 such that the microcontroller 140 controls theactivation/status of the indicator lights 144, 146, and 148.

In addition to and/or in lieu of the indicator lights 144, 146, and 148,the steering device 110 can include other indicators, including audibleand tactile notifications. For example, in some implementations thesteering device 110 is configured to provide force feedback to the userbased on force sensors at the distal portion of the intravascular device(monitoring the amount of force/compression on the distal portion of theintravascular device) and/or force sensors monitoring the amount oftension of the pull-wires and/or the pull-wire wheel anchors. The forcemeasurement(s) can then be conveyed to the user via one or morevibration motors to create haptic feedback (vibration location andmagnitude can vary depending on the sensor(s) detecting a forceexceeding predefined thresholds and/or the magnitude of the forcemeasurement). The force measurements can also be conveyed to the uservia a graphical user interface of an associated processing system, viaillumination of one or more of the indicator lights, and/or an audiblewarning/alarm. Pull-wire tension measurements can also be used toidentify if a particular steering device 110 needs to becalibrated/refurbished by identifying significant drop offs in themaximum actuation force at the maximum motor range when compared to thevalues from original calibration/use.

In cases when steering into tight and complex anatomies are involved,there is a potential need to separate the intravascular device 102 fromthe steering device 110 (e.g., where the steering device is stuckactuated in a specific direction and angle that prevents safe withdrawalof the intravascular device). Accordingly, the steering device 110 caninclude features to facilitate the disengagement of the intravasculardevice 102 from the steering device 110 for safe removal of theintravascular device 102 from the patient. For example, the steeringdevice can include electrical, software, and/or mechanical failsafecomponents. An electrical failsafe can include an on/off switch or aphysical reset button to reset the software logic/electrical hardwareshould the software/hardware hang while the device is being used. Amechanical failsafe can include a built-in blade within the housing 112that when actuated/pressed through a shallow cavity from an outsidesurface of the housing 112 will cut the pull-wires 123 and 125 prior tothe wheels, releasing all tension acting on the intravascular device 102and allowing the intravascular device 102 to return to a relaxed neutralposition for removal. Similarly, the attachable modular shaft adapterdescribed above (i.e., where the adaptor 138 is part of a separatecomponent that can be coupled to the housing 112) can simultaneouslyfunction as a mechanical failsafe. In this regard, should theintravascular device 102 need to be relaxed and the pull-wire tensionreleased, the user can simply disconnect the modular shaft adaptor andthe pull-wire mating interfaces along with it to release the tension.

FIGS. 8 and 9 illustrate additional features of the housing 112. Thehousing 112 includes a top portion 112 a and a bottom portion 112 b. Thetop and bottom portions 112 a and 112 b are configured to couple to oneanother to define housing 112. In this regard, any suitable means ofcoupling may be utilized, including interlock, snap-fit, mechanicalfasteners, adhesives, and/or combinations thereof. Each of the top andbottom portions 112 a and 112 b includes features sized and shaped tointerface with the other components of the steering device.

For example, the top portion 112 a includes a cavity 150 having aportion 152 to receive pull-wire wheels 122 and 124, pull-wires 123 and125, motors 126 and 128, mounting structures 130 and 132, and guide pins134 and 136. The cavity 150 of the top portion 112 a also includes aportion 154 sized and shaped to receive the microcontroller 140 and themounting structure 142. The distal section of the top portion 112 aincludes an opening 158 and a recess 156. The top portion 112 a includesan opening 160 sized to allow the steering controller 118 to passthrough, as well as openings 164, 166, and 168 for indicator lights 144,146, and 148.

The bottom portion 112 b includes a cavity 170 having a portion 172 toreceive pull-wire wheels 122 and 124, pull-wires 123 and 125, motors 126and 128, mounting structures 130 and 132, and guide pins 134 and 136.The cavity 170 of the bottom portion 112 b also includes a portion 154sized and shaped to receive the microcontroller 140 and the mountingstructure 142. The distal section of the bottom portion 112 b includesan opening 178 and a recess 176. Together, the recesses 156 and 176define a cavity in which the adaptor 138 is received. Similarly, theopenings 158 and 178 define an opening through which the intravasculardevice 102 can be inserted into the steering device 110 and, morespecifically, through which the proximal portion of the intravasculardevice 102 can extend through the bore in the adaptor 138. Likewise, thecavities 150 and 170 define the spaces for receiving and mounting theother components of the steering device 110. As noted above, the housing112 is sized and shaped for grasping by a single hand of a user and mayhave many different geometries suitable for handheld use other thanthose shown in the present disclosure.

The steering device 110 can be configured to communicate with one ormore external devices and/or processing systems. In this regard, thecommunications with the external devices and/or processing systems canbe utilized to control operation of the steering device 110, providefeedback on the steering/actuations imparted by the steering device,and/or receive data from sensing elements associated with theintravascular device 102 and/or steering device 110. It is understoodthat any communication pathway between the steering device 110 and theexternal devices and/or processing systems may be utilized, includingphysical connections (including electrical, optical, and/or fluidconnections), wireless connections, and/or combinations thereof. In thatregard, it is understood that the connection is wireless in someinstances. As such, the microcontroller 140 can include or be incommunication with a wireless transceiver positioned within the housing112. In some instances, the connection includes a communication linkover a network (e.g., intranet, internet, telecommunications network,and/or other network). In that regard, it is understood that theexternal devices and/or processing systems can be positioned remote froma procedure room where the steering device 110 is being used in someinstances. Having the connection include a connection over a network canfacilitate communication between the steering device 110 and theexternal devices and/or processing systems regardless of whether theexternal devices and/or processing systems are in an adjacent room, anadjacent building, or in a different state/country. Further, it isunderstood that the communication pathway between the steering device110 and the external devices and/or processing systems is a secureconnection in some instances. Further still, it is understood that, insome instances, the data communicated over one or more portions of thecommunication pathway between the steering device 110 and the externaldevices and/or processing systems is encrypted.

Persons skilled in the art will also recognize that the apparatus,systems, and methods described above can be modified in various ways.Accordingly, persons of ordinary skill in the art will appreciate thatthe embodiments encompassed by the present disclosure are not limited tothe particular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

What is claimed is:
 1. An intravascular steering device, comprising: ahousing configured to be grasped by a hand of a user, the housingincluding a proximal portion and a distal portion, wherein the distalportion includes an opening sized and shaped to receive an intravasculardevice; a steering controller coupled to the housing, wherein thesteering controller is configured to provide electrical signals inresponse to inputs received from the user; and an actuator positionedwithin the housing in communication with the steering controller toreceive the electrical signals, the actuator interfacing with theproximal end of the intravascular device based on the electrical signalsto steer a distal end of the intravascular device, the actuatorcomprising: a first pull-wire wheel coupled to the housing; a secondpull-wire wheel coupled to the housing; a first pull-wire anchored tothe first pull-wire wheel such that rotation of the first pull-wirewheel adjusts tension on the pull-wire to manipulate the proximal end ofthe intravascular device in a first direction; a second pull-wireanchored to the second pull-wire wheel such that rotation of the secondpull-wire wheel adjusts tension on the second pull-wire to manipulatethe proximal end of the intravascular device in a second direction thatis different from the first direction; and a motor configured to rotatethe first and second pull-wire wheels in response to the electricalsignals received from the steering controller and thereby move thedistal end of the intravascular device in the first and seconddirections in response to the inputs from the user.
 2. The intravascularsteering device of claim 1, wherein the steering controller comprises ajoystick.
 3. The intravascular steering device of claim 1, wherein theactuator further comprises a mechanism for controlling movement in athird direction in response to the electrical signals received from thesteering controller, the third dimension being perpendicular to thefirst and second directions.
 4. The intravascular steering device ofclaim 1, wherein the actuator further includes: a mechanism forcontrolling rotation of the intravascular device about a longitudinalaxis of the intravascular device in response to the electrical signalsreceived from the steering controller.
 5. The intravascular steeringdevice of claim 1, wherein the first and second pull-wire wheels areparallel to each other, and wherein the intravascular steering devicefurther comprises at least one steering pin configured to guide andredirect at least one of the first pull-wire and the second pull-wire.6. The intravascular steering device of claim 1, wherein the steeringcontroller further comprises a microcontroller positioned within thehousing and in communication with the actuator, wherein themicrocontroller translates the inputs from the user into the intoelectrical signals.
 7. The intravascular steering device of claim 1,further comprising a haptic feedback device positioned within thehousing, the haptic feedback device configured to provide a haptic alertto a user when a force on the intravascular device exceeds a threshold.8. The intravascular steering device of claim 7, wherein the force onthe intravascular device is measured by at least one of a sensor withinthe housing or a sensor within the intravascular device.
 9. Theintravascular steering device of claim 1, further comprising arechargeable power supply positioned within the housing and a wirelesstransceiver positioned within the housing.
 10. The intravascularsteering device of claim 1, further comprising an adaptor positionedwithin the opening of the housing, the adaptor including a bore that issized and shaped to allow a proximal end of the intravascular device topass therethrough.
 11. The intravascular steering device of claim 10wherein the adaptor is removable and replaceable with other adaptorshaving differently sized bores to accommodate different intravasculardevices.
 12. An intravascular steering device, comprising: a housingsized and shaped for grasping by a hand of a user, the housing includinga proximal portion and a distal portion, wherein the distal portionincludes an opening sized and shaped to receive an intravascular device;a steering controller coupled to the housing to receive mechanicalinputs from a user of the intravascular steering device and to provideelectrical signals in response thereto; and an actuator positionedwithin the housing and in communication with the steering controller,the actuator interfacing with the proximal end of the intravasculardevice based on inputs to the steering controller to steer a distal endof the intravascular device, the actuator comprising: a first pull-wirewheel coupled to the housing; a second pull-wire wheel coupled to thehousing; a first pull-wire anchored to the first pull-wire wheel suchthat rotation of the first pull-wire wheel adjusts tension on the firstpull-wire to manipulate the proximal end of the intravascular device ina first dimension; a second pull-wire anchored to the second pull-wirewheel such that rotation of the second pull-wire wheel adjusts tensionon the second pull-wire to manipulate the proximal end of theintravascular device in a second dimension that is substantiallyperpendicular to the first dimension; and a motor configured to rotatethe first and second pull-wire wheels in response to the electricalsignals received from the steering controller and thereby move thedistal end of the intravascular device in the first dimension and in thesecond dimension.
 13. The intravascular steering device of claim 12,wherein the first and second pull-wire wheels are parallel to eachother, and wherein the intravascular steering device further comprisesat least one steering pin configured to guide and redirect at least oneof the first pull-wire and the second pull-wire.
 14. The intravascularsteering device of claim 12, further comprising an adaptor positionedwithin the opening of the housing, the adaptor including a bore that issized and shaped to allow a proximal end of the intravascular device topass therethrough.
 15. The intravascular steering device of claim 12wherein the adaptor is removable and replaceable with other adaptorshaving differently sized bores to accommodate different intravasculardevices.
 16. The intravascular steering device of claim 12 wherein thefirst and second pull-wire wheels are rigidly coupled to the housing topermit rotation but not translation of the wheel.